- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02313753
Evaluation of the Coping Long Term With Active Suicide Program (CLASP)
June 4, 2021 updated by: Ivan Miller, Butler Hospital
The purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.
Study Overview
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Butler Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current patient at Butler Hospital
- Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS
- Age > 18 years
- Have a reliable telephone
- Ability to speak, read, and understand English well to complete the procedures of the study
Exclusion Criteria:
- Current psychotic symptoms severe enough to impair study participation
- Participation in a treatment program with established efficacy in preventing suicidal behavior
- Cognitive impairment which would interfere with adequate participation in the project (MMSE< 20).
4. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SAFE
Safety Assessment and Follow-up Evaluation Protocol
|
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Experimental: CLASP
Coping Long Term with Active Suicide Program Protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A composite composed of the number of participants with either a suicide attempt or death by suicide
Time Frame: 52 weeks following discharge from hospital
|
As assessed by both the Columbia Suicide Severity Rating Scale and record review
|
52 weeks following discharge from hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
December 5, 2014
First Submitted That Met QC Criteria
December 8, 2014
First Posted (Estimate)
December 10, 2014
Study Record Updates
Last Update Posted (Actual)
June 7, 2021
Last Update Submitted That Met QC Criteria
June 4, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH101129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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